摘要
目的:建立内标法测定乙交酯丙交酯共聚物(PLGA)中单体残留量的气相色谱检测方法。方法:采用气相色谱法进行测定:内标物为乙酸丁酯;色谱柱为DB-5柱(30m×0.53mm,5um);进样口温度为250℃;分流比10:1;载气为氮气;柱温为135℃;检测器为火焰离子检测器(FID),检测器温度为300℃;进样量为3uL。结果:采用气相色谱法测定PLGA中乙交酯与丙交酯的含量,乙交酯与丙交酯的线性范围分别为17.67~83.30和33.33~266.70ug·mL-1,加标回收率分别为99.0%和100.6%,相对标准偏差分别为0.7%和1.0%。结论:经方法学验证,该法简便、快捷、灵敏度高、结果准确,适用于PLGA中乙交酯与丙交酯的检测。
Objective: To establish a quantitative method for determination of lactic and glycolic contents in PLGA by gas chromatography with internal standard substance. Methods: N-butyl acetate was used as an internal standard substance and a capillary gas chromatographic method was carried out. DB-5 capillary column (30 m × 0.53 mm,5 um) was used, the injection port temperature was 250 ℃ , and the split ratio was 10: 1. The carrier gas was nitrogen and the initial column temperature was 135 ℃. The temperature of FID was set at 300 ℃ , and the sample volume was set at 3 uL. Results: The concentration of glycolic and lactic was linearly within 17.67 - 83.30 and 33.33 -266.70 ug. mL-1, respectively. The recovery of glycolic and lactic was 99.0% and 100.6% , and the relative standard deviation was 0.7% and 1.0%. Conclusion: The method is simple, rapid, sensitive and accurate. It is suitable for the content determination of residual lactic and glycolic in PLGA.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2014年第4期403-406,共4页
Chinese Journal of New Drugs
基金
国家"重大新药创制"科技重大专项(2013ZX09509106)
关键词
内标
气相色谱法
PLGA
乙交酯
丙交酯
internal standard substance
gas chromatography
PLGA
lactic
glycolic